18 results · 39ms · Sources: EU EUDAMED, US FDA

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T2 RECON NAIL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032898·Baltic Denture System BDLoad Ln6 PLSEbil2DFl B3...

CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

ST. JOSEPH HSP BALTIMORE MD1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DWF·October 1, 2010

EMAX MOTOR

FDA Adverse Event
Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·March 29, 2013

MINICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·March 29, 2011

LIFESHIELD CONV SOLUSET

FDA Adverse Event
Malfunction ·HOSPIRA DE COSTA RICA LTD.·Product code FPK·April 23, 2008

CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·December 23, 2020

CHILDRENS MERCY KS CITY MO1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010

SMART, PERFUSION PACKS, CONNECTORS, TUBING

FDA Adverse Event
Malfunction ·LIVANOVA USA·Product code DWE·August 1, 2023

CSC14 CARDIOLOGIA HEAT EXCHANGER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·April 20, 2023

CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTR·March 10, 2016

CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTR·November 20, 2015

CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·October 18, 2019

CHILDRENS MERCY KS CITY MO1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024